Senior Clinical Research Specialist

vor 4 Wochen

Wien, Wien, Österreich Thermo Fisher Scientific Vollzeit

Job Description:



We are seeking a highly skilled Senior Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Senior CRA, you will play a critical role in the success of our clinical trials by ensuring that investigator sites are compliant with regulatory requirements and that data is accurate and complete.



Responsibilities:





  • Monitor investigator sites using a risk-based approach, applying root cause analysis and critical thinking skills to identify site processes failures and implement corrective actions

  • Ensure data accuracy through SDR, SDV, and CRF review, as applicable, during on-site and remote monitoring activities

  • Conduct physical inventory and records reviews to assess investigational product

  • Document observations in reports and letters in a timely manner, adhering to approved business writing standards

  • Raise observed deficiencies and issues to clinical management promptly and follow through to resolution

  • Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolve identified issues, and ensure timely data recording

  • Participate in investigator meetings and contribute to project publications/tools

  • Initiate clinical trial sites according to relevant procedures, ensuring compliance with protocols and regulatory/ICH GCP obligations

  • Ensure trial close-out and retrieval of trial materials

  • Verify completeness and availability of required essential documents according to ICH-GCP and applicable regulations

  • Conduct on-site file reviews as per project specifications

  • Facilitate effective communication among investigative sites, client company, and PPD project team through written, oral, and/or electronic contacts

  • Respond to company, client, and applicable regulatory requirements/audits/inspections

  • Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner



Requirements:





  • Bachelor's degree in a life sciences related field or Registered Nursing certification/equivalent and relevant formal academic/vocational qualification

  • Previous experience providing knowledge, skills, and abilities comparable to 2+ years as a clinical research monitor

  • Valid driver's license (where applicable)



Salary: $85,000 - $110,000 per annum, depending on location and experience

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